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Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section

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ClinicalTrials.gov Identifier: NCT03464253
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, Zagazig University

Brief Summary:

The parturients are at particular risk of post dural puncture headache (PDPH) because of their sex, young age, and the widespread application of spinal and epidural anesthesia. PDPH has a negative impact on quality of life, patient satisfaction, the postpartum experience with the mother's inability to bond with and care for her baby and it increases the economic burden associated with childbirth. Therefore, it is necessary to prevent or decrease its incidence and severity.

TCD enables measurement of the blood flow velocity in intracranial arteries and its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.


Condition or disease Intervention/treatment
Postdural Puncture Headache Device: Performance of the transcranial Doppler (TCD)

Detailed Description:

PDPH is described as severe "searing and spreading like hot metal" distributed over the occipital and frontal areas radiating to the neck and shoulders. 90% of headache will occur within three days of the procedure, and 66% within the first 48 hours. The PDPH rarely develops between 5 and 14 days after the technique however it may immediately occur after dural puncture but it is rare and should pay attention of the physician to alternative causes. The pain is increased by head movement, upright posture and relieved by lying down. It resolves either spontaneously within 7 days or within 48 h after effective treatment which is usually consists of fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.

The exact etiology of PDPH is unknown; there is two hypothesis attempts to explain the cause. First it's known that dural tear leads to cerebrospinal fluid (CSF) leak and decreased volume of CSF result in intracranial hypotension which cause on pain sensitive intracranial structures that become stretched when assuming upright position result in pain. Second, intracranial volume is constant and equal to the sum of intracranial blood, CSF, and brain matter. After loss of CSF a compensatory reflex vasodilatation occur in the same pain sensitive blood vessels and this result in pain.

The association of common risk factors like female gender, particularly females during pregnancy, age groups of 20 - 40 years, a prior history of chronic headache, and a lower body mass index expose the patient to PDPH. The identification of factors that predict the likelihood of PDPH is important so that measures can be taken to minimize this painful complication resulting from spinal anesthesia.

Transcranial Doppler ultrasound (TCD) is a portable, safe, noninvasive and real-time tool for assessing intracranial blood hemodynamics. The first description of the technique was by Rune Aaslid in early 20th century and it has gained increasing acceptance as an accurate diagnostic and therapeutic tool in both cerebrovascular disease and neurocritical care. TCD enables measurement of the blood flow velocity in intracranial arteries and several Studies have shown that its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. So, as PDPH may be resulted from significant changes in cerebral blood flow, it could be visualized by TCD.

The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Days
Official Title: Transcranial Doppler Role in Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Performance of the transcranial Doppler (TCD)
    Within 24 hour before the operation, TCD is performed using Siemens Acuson X300 machine with ultrasound frequency is 1 - 5 MHz probe to measure Mean Velocity and Pulsatility Index in the right middle cerebral artery.postoperatively, TCD study is performed twice at 24h and 48h after spinal anesthesia. For 5 days postoperatively, the Patients are assessed clinically for the occurrence of headache. Patients who developed PDPH will be identified and their pre and post puncture measurements will be compared with the corresponding measurements of PDPH free patients.


Primary Outcome Measures :
  1. TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section [ Time Frame: 5 days ]
    The group of patients who developed PDPH will be identified and their pre puncture cerebral blood flow measurements by TCD will be compared with the corresponding measurements of PDPH free patients to correlate the pre-puncture measurements with the occurrence of PDPH.


Secondary Outcome Measures :
  1. verify that lumber puncture in PDPH patients leads to significant changes in cerebral blood flow supporting the theory of cerebral vasodilatation in PDPH patients. [ Time Frame: 5 days ]
    The post-puncture TCD measurements will be compared to verify that lumber puncture and CSF leak leads to reflex vasodilatation in PDPH patients.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant female undergoing Elective caesarean section under spinal anesthesia.
Criteria

Inclusion Criteria:

  • Patient acceptance.
  • Pregnant female undergoing Elective caesarean section under spinal anesthesia.
  • Age 18-40 years old.
  • ASA I and ASA II.
  • Accepted mental state of the patient.

Exclusion Criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia as local infection, coagulopathy,….etc
  • ASA Grade 3 and 4.
  • Emergent caesarean section.
  • Inadequate temporal window.
  • Hypertensive disorders of the pregnancy.
  • Atrial fibrillation.
  • Significant fetal illness.
  • History of allergy to local anesthetics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464253


Contacts
Contact: Sherif MS Mowafy, MD 01003523374 ext 002 sherifmowafy2012@gmail.com
Contact: Shereen E Abd Ellatif, MD 01007948840 ext 002 shosh.again@gmail.com

Locations
Egypt
Zagazig University Hospitals Recruiting
Zagazig, Sharkia, Egypt, 44111
Contact: Shereen E Abd Ellatif, MD    01007948840 ext 002    shosh.again@gmail.com   
Contact: Sherif MS Mowafy, MD    01003523374 ext 002    sherifmowafy2012@gmail.com   
Sponsors and Collaborators
Zagazig University
Investigators
Study Director: Shereen E Abd Ellatif, MD Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Principal Investigator: Sherif MS Mowafy, MD Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University

Publications:
Mohammed EL and El Shal SM. Efficacy of different size Quincke spinal needles in reduction of incidence of Post-Dural Puncture Headache (PDPH) in Caesarean Section (CS). Randomized controlled study. Egyptian Journal of Anaesthesia 33: 53-58, 2017
Shah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 46(5):373-377, 2002
Kracoff SL and Kotlovker V. Post Dural Puncture Headache—Review and Suggested New Treatment. Open Journal of Anesthesiology 6: 148-163, 2016

Responsible Party: Sherif M. S. Mowafy, lecturer of Anesthesia and Surgical Intensive Care, Zagazig University
ClinicalTrials.gov Identifier: NCT03464253     History of Changes
Other Study ID Numbers: 4372/25-2-2018
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: the IPD and any additional supporting information will become available starting 6 months after publication.
Access Criteria: by contacting the study director

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases